Organ transplantation is often the only treatment for end stage organ failure, such as liver and heart failure. Surgical replacement of a diseased organ by transplantation with a normal organ obtained from a donor can be a life-saving procedure. Unfortunately, normal bodily immune defense mechanisms recognize such solid organ transplants as foreign and attack them, resulting in graft failure and rejection. Transplantation of several organs, including kidney, liver, heart, and lungs has been achieved with varying degrees of success by employing immunosuppressive drugs to interfere with immune-mediated graft rejection. Unfortunately, there is no one single immunosuppressive agent or technique which is useful in all settings involving organ transplantation, and all of the agents currently available have serious drawbacks and deleterious side effects. The usefulness of many of the agents is limited by their toxicity. In some cases, this associated toxicity may actually hinder the normal functioning of the transplant itself. Additionally, the use of such immunosuppressive agents weakens the immune system of the recipient, often making them highly vulnerable to infections.
Despite significant advances in the understanding of tissue typing (series of diagnostic tests to determine the molecular compatibility of donor and recipient) and immunosuppression therapies since the first solid organ transplant over 60 years ago, acute rejection remains a serious clinical problem only partially controlled by current immunosuppressive drugs (e.g., cyclosporine, monoclonal antibodies). In the absence of successful therapies, rejection will lead to graft failure, which, in turn, leads to recipient death or reinstitution of other procedures (e.g., dialysis for kidney patients). Thus, there remains a need in the art for a safe, effective means for preventing and/or reducing the incidence of graft rejection of solid organ transplants using a human birth tissue construct.